Duns Number:044611812
Device Description: BardPort M.R.I. Low-Profile Implantable Port with Pre-Attached 6.6F Open-Ended Single-Lume BardPort M.R.I. Low-Profile Implantable Port with Pre-Attached 6.6F Open-Ended Single-Lumen Venous Catheter Intermediate Kit
Catalog Number
6603880
Brand Name
M.R.I. Low-Profile Implantable Port
Version/Model Number
6603880
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
ad8a1d4d-8d61-4a0b-8160-dd06a9f28678
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
July 13, 2015
Package DI Number
10801741027410
Quantity per Package
5
Contains DI Package
00801741027413
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |